Pulmonary Rehabilitation in Interstitial Lung Diseases

Overview

Treatment in interstitial lung diseases (ILD) is frequently ineffective. Pulmonary rehabilitation (PR) is an excellent therapeutic option in another chronic lung diseases such as chronic obstructive pulmonary disease (COPD). This prospective randomized controlled study aims to evaluate the short and long-term effects of PR in patients with ILD. For this purpose, 60 ILD patients will be randomly assigned to a PR or a control group.

The investigators hypothesize that PR will improve exercise capacity, increase muscle force, reduce dyspnea and improve quality of life and daily life activities in ILD patients.

Full Title of Study: “Effects of Pulmonary Rehabilitation in Interstitial Lung Diseases: a Prospective Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2011

Interventions

  • Other: Pulmonary Rehabilitation
    • The intervention group will perform a 6 month pulmonary rehabilitation program which consists of training, patient education, nutrition counseling and psychosocial support. They will be evaluated with some tests for the study.

Arms, Groups and Cohorts

  • Active Comparator: 1
    • Pulmonary Rehabilitation
  • No Intervention: 2

Clinical Trial Outcome Measures

Primary Measures

  • changes in six minute walking distance after 6 months
    • Time Frame: 6 months
    • primary outcome of rehabilitation programm

Secondary Measures

  • Changes in dyspnea and quality of life scores (MMRC, CRDQ, SGRQ),
    • Time Frame: 3-6-12 months
  • Change in peripheral and respiratory muscle force
    • Time Frame: 3-6-12 months
  • Change in maximal exercise capacity
    • Time Frame: 3-6-12 months
  • Change in daily physical activity measured by Sensewear armband
    • Time Frame: 3-6-12 months
  • Changes in pulmonary function and blood gases at rest
    • Time Frame: 3-6-12 months
  • Change number of disease-related hospitalizations and survival
    • Time Frame: 3-6-12 months
  • Change in functional exercise capacity measured by the 6 minute walking distance
    • Time Frame: 12 months
  • To evaluate feasibility and safety of pulmonary rehabilitation in interstitial lung disease
    • Time Frame: 6 months
  • Changes in six minute walking distance
    • Time Frame: at 3, 12 months

Participating in This Clinical Trial

Inclusion Criteria

  • Diagnosis of interstitial lung disease according to internationally established criteria
  • Dyspnea on exertion
  • Stable medical therapy
  • Stable clinical condition at inclusion, with no infection or exacerbation in the previous 4 weeks

Exclusion Criteria

  • Co-morbidities that do not allow exercise training (unstable angina, recent myocardial infarction or cerebrovascular accident, active cancer, severe orthopedic disorders).
  • Life expectancy below 3 months

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • KU Leuven
  • Provider of Information About this Clinical Study
    • Principal Investigator: Marc Decramer, Prof. Dr. – KU Leuven
  • Overall Official(s)
    • Silvia PĂ©rez-Bogerd, MD, Principal Investigator, KU Leuven
    • Wim Janssens, MD PhD, Principal Investigator, KU Leuven
    • Wim Wuyts, MD PhD, Principal Investigator, KU Leuven

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